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Not yet recruiting NCT07288463

Hearing Loss and Brain Health Study

No phase Interventional Hearing Loss, Adult-Onset Dementia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Over-The-Counter (OTC) hearing aid.
Who it may be relevant to
Registry conditions: Hearing Loss, Adult-Onset, Dementia. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Hearing loss is a prevalent and modifiable risk factor for cognitive decline and dementia in older adults, yet access to hearing care remains limited. Over-the-counter (OTC) hearing aids represent a promising and scalable strategy to expand access, particularly for individuals at elevated risk for dementia who may benefit most from earlier intervention. This pilot study aims to evaluate the feasibility and acceptability of OTC hearing aid use among older adults. Participants aged ≥50 years will undergo standardized hearing screening to identify bilateral, mild-to-moderate hearing loss. Eligible participants will be randomized to one of two sequences: (1) immediate intervention: 3-mo using OTC hearing aids or (2) waitlist control: 3-mo without devices followed by OTC hearing aid use after 3 months. Feasibility outcomes include study enrollment and retention, protocol adherence, and average daily device use determined by data-logging. Acceptability outcomes will be assessed using the International Outcome Inventory for Hearing Aids (IOI-HA), device satisfaction ratings, and participant intention to continue hearing-aid use. Hearing outcomes include validated questionnaires on hearing and listening efforts. Findings will inform the design of larger trials aimed at improving access to hearing care and promoting cognitive health.

Interventions

  • Device Over-The-Counter (OTC) hearing aid
    Over-The-Counter (OTC) hearing aid

Primary outcome measures

  • Feasibility- Proportion of enrolled participants who complete all study periods [Time frame: Baseline, 3 months, and 6 months follow-up]
  • Feasibility - Enrollment rate (% eligible who consent) [Time frame: Baseline]
  • Feasibility - Study visit completion rate (% of planned visits completed) [Time frame: Baseline, 3 months, and 6 months follow-up]
  • Feasibility - Frequency of device troubleshooting encounters [Time frame: Baseline, 3 months, and 6 months follow-up]
  • Feasibility - Percentage achieving >= 6hours/day of objective wear time [Time frame: Baseline, 3 months, and 6 months follow-up]
  • Feasibility - Hearing aid use adherence (mean daily wear time from data-logging) [Time frame: Baseline, 3 months, and 6 months follow-up]
  • Feasibility - Protocol adherence rate (% completing scheduled assessments) [Time frame: Baseline, 3 months, and 6 months follow-up]
  • Feasibility - Retention rate (% completing follow-up visits) [Time frame: Baseline, 3 months, and 6 months follow-up]
  • Acceptability - International Outcome Inventory for Hearing Aids [Time frame: Baseline, 3 months, and 6 months follow-up]
  • Acceptability - Intention to continue use after study completion [Time frame: Baseline, 3 months, and 6 months follow-up]
Secondary outcome measures (2)
  • Hearing Handicap Inventory - Screening Version [Time frame: Baseline, 3 months, and 6 months follow-up]
  • Vanderbilt fatigue scale [Time frame: Baseline, 3 months, and 6 months follow-up]

Eligibility criteria

Inclusion criteria

  • Age >= 50 years
  • Known APOE status
  • Bilateral mild to moderate sensorineural hearing loss
  • No current use of hearing aids or cochlear implants
  • No diagnosis of dementia and able to provide informed consent
  • Able to complete questionnaires and follow instructions in English
  • Willing and able to comply with study procedures, follow-up visits, and hearing-aid use

Exclusion criteria

  • Clinical diagnosis of dementia
  • Severe or profound hearing loss
  • Self-reported congenital hearing loss
  • Absence of an ear canal due to medical conditions or prior surgical procedures
  • unwillingness to wear OTC hearing aids regularly (>=4 hours/day)
  • medical contraindication to use hearing aids (e.g., actively draining ear)
  • Known retrocochlear pathology
  • Severe uncorrected visual impairment or significant manual dexterity limitations that prevent handling the device

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Southern California — Los Angeles

Identifiers

NCT: NCT07288463 · APP-25-05793

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗